HydrocephalusNCT06629168
The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.
An observational study of Hydrocephalus and Normal Pressure Hydrocephalus, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hydrocephalus, Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus Patients
- What is being tested?
- lumbar puncture, External lumbar drainage and Ventriculo-peritoneal shunt placement
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected based on inclusion criterias, with communicating hydrocephalus
Who may be able to join
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test > 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
Who cannot join
- Non-communicating hydrocephalus
- Structural lesion on MRI or CT (tumour, contusion, aneurysm)
- mini-mental state examination test < 10 points
- Life-expectancy shorter than 1 year
- Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
- Surgery lasting more than 120 minutes
- Blood loss more than 500 ml
- Adverse events during general anesthesia: mean arterial pressure < 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus
Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.
Read the detailed description
Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Diagnosing NPH is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. However, treatment from a neurosurgical perspective does not end there. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.
- Being tested
- lumbar puncture, External lumbar drainage, Ventriculo-peritoneal shunt placement, Follow-up control #1, Follow-up control #2
- Keywords
- Normal pressure hydrocephalus, VP drainage, telemetry, pressure monitoring
- Medical subject headings
- Hydrocephalus, Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar punctureDiagnostic test
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and 10-meter-walking test prior and 4 hours after lumbar puncture. Mini-mental state examination is done.
External lumbar drainageDiagnostic test
External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement
Ventriculo-peritoneal shunt placementProcedure or surgery
Surgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally). Telemetric prechamber placement according the randomization (www.randomization.com) and the envelope method of choosing of patients.
Follow-up control #1Diagnostic test
Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.
Follow-up control #2Diagnostic test
Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.
Follow-up control #3Diagnostic test
Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.
Follow-up control #4Diagnostic test
Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score a month after surgery. Brain CT control, 10-meter-walking test, MMSE, self-assessment.
Telemetric prechamber readingDiagnostic test
Non-invasive reading of telemetric prechamber made during each follow-up control.
Valve setting changeOther
Changing of valve setting according patient's actual condition. Decission based on clinical state, radiological finding on CT and values readed from telemetric prechamber. Timing - each follow-up control.
| Study group | Role | What they receive |
|---|---|---|
| Study group "Telemetrics" | Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Receives: Diagnostic Test: lumbar puncture; Diagnostic Test: External lumbar drainage; Procedure: Ventriculo-peritoneal shunt placement; Diagnostic Test: Follow-up control #1; Diagnostic Test: Follow-up control #2; Diagnostic Test: Follow-up control #3; Diagnostic Test: Follow-up control #4; Diagnostic Test: Telemetric prechamber reading; Other: Valve setting change | |
| Study group "Normal" | Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Receives: Diagnostic Test: lumbar puncture; Diagnostic Test: External lumbar drainage; Procedure: Ventriculo-peritoneal shunt placement; Diagnostic Test: Follow-up control #1; Diagnostic Test: Follow-up control #2; Diagnostic Test: Follow-up control #3; Diagnostic Test: Follow-up control #4; Other: Valve setting change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient's state
Comparison of mini-mental state examination, gait (measured by 5-meter-walking) test a self-assessment made by patient between both group (telemetric prechamber impanted versus not implanted)
Measured: 3 month
Secondary outcomes (3)
Comparison in radiological findings
Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups
Measured: 1 year
Comparison in number of valve setting
Comparison in number of valve setting between both groups
Measured: 1 year
Comparison of difference in valve settings
Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2018
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miroslav Cihlo, University Hospital Hradec Kralove
- Investigators
- Miroslav Cihlo, M.D., Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629168
- Sponsor's protocol ID
- MC00003
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus
- ClinicalTrials.gov ID
- NCT06629168
- Acronym / sponsor ID
- MC00003
- Keywords
- Normal pressure hydrocephalus, VP drainage, telemetry, pressure monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.
Detailed description
Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Diagnosing NPH is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. However, treatment from a neurosurgical perspective does not end there. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group "Telemetrics" | – | Diagnostic Test: lumbar puncture, Diagnostic Test: External lumbar drainage, Procedure: Ventriculo-peritoneal shunt placement, Diagnostic Test: Follow-up control #1, Diagnostic Test: Follow-up control #2, Diagnostic Test: Follow-up control #3, Diagnostic Test: Follow-up control #4, Diagnostic Test: Telemetric prechamber reading, Other: Valve setting changePatients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. |
| Study group "Normal" | – | Diagnostic Test: lumbar puncture, Diagnostic Test: External lumbar drainage, Procedure: Ventriculo-peritoneal shunt placement, Diagnostic Test: Follow-up control #1, Diagnostic Test: Follow-up control #2, Diagnostic Test: Follow-up control #3, Diagnostic Test: Follow-up control #4, Other: Valve setting changePatients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected based on inclusion criterias, with communicating hydrocephalus
Key inclusion criteria (4 listed)
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test > 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
Key exclusion criteria (8 listed)
- Non-communicating hydrocephalus
- Structural lesion on MRI or CT (tumour, contusion, aneurysm)
- mini-mental state examination test < 10 points
- Life-expectancy shorter than 1 year
- Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar punctureStandardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and 10-meter-walking test prior and 4 hours after lumbar puncture. Mini-mental state examination is done. | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| External lumbar drainageExternal lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| Ventriculo-peritoneal shunt placementSurgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally). Telemetric prechamber placement according the randomization (www.randomization.com) and the envelope method of choosing of patients. | Procedure or surgery | Study group "Normal", Study group "Telemetrics" |
| Follow-up control #1Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control. | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| Follow-up control #2Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control. | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| Follow-up control #3Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control. | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| Follow-up control #4Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score a month after surgery. Brain CT control, 10-meter-walking test, MMSE, self-assessment. | Diagnostic test | Study group "Normal", Study group "Telemetrics" |
| Telemetric prechamber readingNon-invasive reading of telemetric prechamber made during each follow-up control. | Diagnostic test | Study group "Telemetrics" |
| Valve setting changeChanging of valve setting according patient's actual condition. Decission based on clinical state, radiological finding on CT and values readed from telemetric prechamber. Timing - each follow-up control. | Other | Study group "Normal", Study group "Telemetrics" |
Primary outcome
Comparison of patient's state
Time frame: 3 month
Comparison of mini-mental state examination, gait (measured by 5-meter-walking) test a self-assessment made by patient between both group (telemetric prechamber impanted versus not implanted)
3 secondary outcomes
Comparison in radiological findings
Time frame: 1 year
Comparison in number of valve setting
Time frame: 1 year
Comparison of difference in valve settings
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Cihlo, M.D. principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Normal Pressure Hydrocephalus, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of patient's state (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.